基于患者报告的运动神经元病结局评价量表的研制及第一轮科学性考评  

Development and the first-round assessment for patient-reported outcomes scale for motor neuron disease

作　　者：韩奕 张斌龙[1,3] 李建军 高颖[1] HAN Yi;ZHANG Binlong;LI Jianjun;GAO Yin(The First School of Clinical Medicine of Beijing University of Chinese Medicine,Beijing 100700,China)

机构地区：[1]北京中医药大学第一临床医学院,北京100700 [2]北京中医药大学 [3]中国中医科学院广安门医院 [4]河北以岭医院

出　　处：《山东医药》2020年第11期16-20,共5页Shandong Medical Journal

基　　金：中国博士后科学基金面上资助项目(2019M650594)。

摘　　要：目的研制基于患者报告的运动神经元病(MND)结局评价量表,并进行第一轮科学性考评。方法使用经典测量理论,创建MND量表条目池,采用Delphi法进行条目筛选,制定出基于患者报告的MND结局评价量表。进行第一轮科学性考评,分析量表的可行性(20例MND患者量表测评的回收率、有效率及测评完成时间)、项目区分度(各条目与量表总分的Spearman相关系数)、信度(折半信度、克朗巴哈α系数)、效度(拟合优度指数)。结果基于患者报告的MND结局评价量表,共包含核心症状、全身症状、心理精神、社会关系等4个维度、16个可操作性高的条目。可行性分析结果显示,回收率100%,有效率100%,测评完成时间(5.7±2.3)min。项目区分度分析结果显示,站立、行走、拿取物品、翻身、穿衣、夜间呼吸、肌肉跳动、饮水呛咳、言语、抬头、睡眠、疲劳、治疗渴望、急躁、对家人态度、人际交往与量表总分的Spearman相关系数分别为0.619、0.507、0.620、0.430、0.825、0.722、0.589、0.681、0.637、0.498、0.219、0.217、0、0.602、0.606、0.606,其中翻身、治疗渴望、睡眠、疲劳4个条目的Spearman相关系数低于0.447(样本量为20例时的Spearman相关系数界值为0.447)。信度分析结果显示,折半信度为0.73,克朗巴哈α系数为0.81。效度分析结果显示,拟合优度指数为0.57。结论成功研制出基于患者报告的MND结局评价量表,并经第一轮科学性考评验证该量表可行性、信度、效度均良好;该量表可较好反映MND患者总体疾病情况变化,为临床评价MND提供了新的方法。Objective To develop and conduct the first-round assessment for the patient-reported outcomes scale for motor neuron disease(MND-PRO).Methods Based on the classical test theory,we developed the item bank and used Delphi method to screen the items to build the script MND-PRO.We used the feasibility parameter(recovery rate,efficiency and completion time),discrimination parameter(Spearman correlation within each items and with the total score),reliability(half-reliability,Cronbach′sαcoefficient)and validity(goodness of fit index,GOF)to assess the MND-PRO.Results The MND-PRO included 4 dimensions(core symptoms,systemic symptoms,psychosocial,and social relationships)and 16 items.The feasibility parameter showed that the recovery was 100%,the effective was 100%,and the completion time was(5.7±2.3)mins.Spearman correlation coefficients between all items(standing,walking,taking items,turning in bed,dressing,nocturnal breathing,muscle fibrillation,drinking,coughing,speech,raising head,sleep,fatigue,craving for treatment,irritability,attitude towards family members,interpersonal communication)and the total score were 0.619,0.507,0.620,0.430,0.825,0.722,0.589,0.681,0.637,0.498,0.219,0.217,0,0.602,0.606,and 0.606.The Spearman correlation coefficient of items(turning over,treatment craving,sleeping,and fatigue)were lower than 0.447(the cut-off value was 0.477 when there were 20 samples).The reliability showed that the half-reliability was 0.73,and the Cronbach'sαcoefficient was 0.81.The validity analysis showed that the GOF index was 0.57.Conclusions The MND-PRO is developed and shows good feasibility,reliability,and validity after the first-round assessment.The MND-PRO can reflect the changes in the overall disease status of MND patients and provide a new approach to clinically evaluate MND.

关 键 词：运动神经元病 基于患者报告的结局量表 科学性考评 

分 类 号：R742[医药卫生—神经病学与精神病学]